Taking a step beyond static X-ray images, the OrthoSonos™ system detects friction across a joint's full range of motion, giving surgeons a clearer picture of patients' joint health. Designed by Karten Design.

Bringing a consumer product to market is a challenge in and of itself—taking an idea through concept development, business analysis, beta testing, product launch, and beyond. Add the FDA to the mix, and it's a whole 'nother story. This is the challenge faced by medical device and product firms, which not only have to make a fully functioning, well-designed product but also have to put it through several rounds of rigorous testing by the FDA and other regulatory bodies.

"They're parameters. They don't stop you from doing anything, but they do make you do it in a way that you, as a user, would probably think is a good thing," says Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica, an FDA-registered product development firm with an exclusive focus on medical products. On any given day, Ximedica is running 40 individual programs, overseeing the steps required to bring these products to market. "We don't do anything that isn't a FDA-regulated product," says Petrie.

The timelines for these projects can run anywhere between two to six years. While time-to-market is not the primary driver, finding ways to close that gap can make a big difference in profitability. For companies like Ximedica and HS Design, closing that gap meant becoming International Organization for Standardization (ISO) 13485 certified. "There are so many regulatory and quality metrics that had to be put in place to satisfy those requirements that it made us a better and stronger company," explains Tor Alden, Principal and CEO at HS Design (HSD). "It also put us to a level where we couldn't just accept any client. We had to become more sophisticated as far as who our clients were and how we could say no or reach a point of compliancy." By building those regulations into the design process, these companies are able to anticipate and plan for any potential timely obstacles from the get-go.

As the products become increasingly complex, so too do the regulations around how they're developed. Traceability of every decision is required for ISO and FDA compliance, ensuring that medical device firms have a standardized quality management process that they follow and document every step of the product's development. Depending on the type of product, specialists are often brought in to advise different aspects of that process. "There are so many parts to the puzzle," says Petrie. "We have 140 people, but we still need specialists all over the place. We have regulatory people on staff, but we also bring in other pieces that we need. While all the people we have in the building are experts in medical device development, when we need someone to develop some optics, we go outside for that. It's very collaborative because nobody can do it all by themselves."

As an FDA-registered developer and contract manufacturer, Ximedica takes products all the way through to clinical trials—a part of the process that comes with its own set of requirements all its own. Even a product as benign as a toothbrush, for example, calls for regulations under HIPPA if it is being tested by people over the age of 65, under 18, or those living with certain medical conditions. Being able to connect these requisitions to product features in the beginning would allow a project manager to track deliverables and foresee any hurdles before the final design goes to Verification and Validation.

Companies like Dassault Systèmes hope to offer a holistic approach to these problems. Similar to how Ximedica has positioned themselves as the one-stop-shop for all of the components needed to bring a medical product to market, Dassault's Ideation & Concept Design for Medical Device creates a space for designers, marketers, specialists, and collaborators to bring an idea through all the phases of the design process. Powered by their 3DEXPERIENCE® platform, Ideation & Concept Design for Medical Device brings together automated market listening, 3D-drawing to 3D-design integration, traceability, and project management together in one program—in the cloud.

"It's very challenging to get a medical product to market in less than two years," explains Alden. "A lot of it has to do with how challenging it is from the FDA standpoint and getting it through the regulatory bodies, but a lot of it is making sure that everybody is working with the same sheet music. Most important is to capture the user needs upfront and translate them into quantifiable attributes. Additionally we need to combine these user needs with the technical issues into a product requirement specification. Managing all these aspects of a project, understanding all the players, and the regulatory milestones is vital to shortening the time to market."

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